Associate Director, Clinical Study Management, EMEA/LATAM
Eikon Therapeutics · Millbrae, CA · 4 wk ago
HybridResearch$183k–$221k/yrFull-time
We need to produce HTML fragment with sections: headings for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections if posting has real specific content. We need to parse the posting.
We have:
- Intro paragraph about Eikon Therapeutics (company description). Could be "About the role"? Actually "About the role" is a heading for description of role. The posting includes "Position The Associate Director, Clinical Study Management, EMEA/LATAM will be responsible for overseeing the execution of clinical trials..." That's role description. So we can put that under
for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections if posting has real specific content. We need to parse the posting.
We have:
- Intro paragraph about Eikon Therapeutics (company description). Could be "About the role"? Actually "About the role" is a heading for description of role. The posting includes "Position The Associate Director, Clinical Study Management, EMEA/LATAM will be responsible for overseeing the execution of clinical trials..." That's role description. So we can put that under About the role
with paragraphs.
- "About You" maybe could be "Skills" or "Qualifications"? Actually "About You" describes desired attributes: collaborative, solutions oriented, flexible, global clinical operational experience, passion for excellence in advancing patient care in oncology or neuroscience. That's more like "Skills" or "Qualifications". But we have separate Qualifications section later. So we could treat "About You" as "Skills" (soft skills). Or we could combine into "Qualifications". However we need to follow instruction: Use headings only when posting has real specific content. We have a "Qualifications" section later with bullet list of qualifications. So we can have Qualifications
with list.
- Responsibilities: The "What You’ll Do" section enumerates duties. That's responsibilities. So Responsibilities
with list.
- Benefits: The posting lists benefits: "At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including: ..." then list of benefits. So we can have Benefits
with list.
- Pay: The posting includes "The expected salary range for this role is $183,000 to $220,500 depending on skills, competency, and the market demand for your expertise." So we can have Pay
with paragraph.
- Schedule: The posting includes onsite presence requirement: "This role will require onsite presence a minimum of 3 days a week..." and later "This role requires a minimum of 3 days per week onsite (or more, as business needs require) in either our Jersey City (NJ), or Millbrae (CA) offices." So schedule info: onsite 3 days/week, locations. So we can have Schedule
with paragraph.
- Possibly "About the role" we already used. Also maybe "About You" could be "Skills". But we already have Qualifications covering education, experience, language, etc. The "About You" is more about personal attributes; could be placed under "Skills". However we might not need a separate Skills section if we can incorporate those attributes into Qualifications or Responsibilities. But we have Qualifications already covering education, experience, language, knowledge, etc. The "About You" includes collaborative, solutions oriented, flexible, global clinical operational experience, passion for excellence in advancing patient care in oncology or neuroscience. Those are skills/attributes. We could create a Skills
section with list. However we need to ensure we don't create thin sections. It's substantive enough.
But we also have "Qualifications" which includes many items. Could we merge "About You" into Qualifications? The instruction: "Prefer a few substantive sections over many thin ones." So maybe better to combine "About You" into Qualifications or Skills? Since Qualifications already includes many bullet points, we could add those attributes as part of Qualifications list. However the Qualifications section currently includes: Minimum of 10 years related experience with Bachelor's; or 8 years and postgraduate degree; Fluency in English; ability to speak multiple EMEA/LATAM languages is a plus; In-depth knowledge of ICH-GCP, EMEA/LATAM guidelines; Proven ability to manage clinical studies within timelines and budgets while maintaining high quality standards and patient safety; Strong leadership and communication skills; Experience with management of budget, resources, headcount, processes and controls, productivity, quality and project delivery; High sense of accountability and urgency; Growth mindset and capable of working independently.
The "About You" attributes: collaborative, solutions oriented, flexible, global clinical operational experience, passion for excellence in advancing patient care in oncology or neuroscience. Some of these overlap with Qualifications (global clinical operational experience maybe covered by experience; collaborative, solutions oriented, flexible, passion for excellence). Could be added to Qualifications list.
Thus we could have Qualifications section that includes both the bullet list from Qualifications and the About You attributes. That would avoid a separate Skills section.
Thus sections: About the role (description), Responsibilities (What You’ll Do), Qualifications (including education, experience, language, knowledge, skills, attributes), Benefits, Pay, Schedule.
We must not repeat job title as heading. We must not include Job ID/requisition numbers. We must remove boilerplate: EEO, equal opportunity, scam warning, etc. Also remove duplicated lines, navigation, cookie, legal, application instructions. The posting includes at end: "Eikon is proud to be an equal opportunity employer..." and third-party agency stuff. Remove those.
Also remove duplicated lines: The phrase "This role requires a minimum of 3 days per week onsite (or more, as business needs require) in either our Jersey City (NJ), or Millbrae (CA) offices." appears similar to earlier "This role will require onsite presence a minimum of 3 days a week to ensure effective management...". We should keep only one instance, but preserve all substantive information; we can combine but not duplicate. We'll include schedule paragraph that mentions minimum 3 days onsite, possibly more as needed, locations Jersey City NJ or Millbrae CA.
Now produce HTML fragment.
Structure:
About the role
... description ...
Responsibilities
- ... each duty ...
Qualifications
- ... each qualification ...
Benefits
- ... each benefit ...
Pay
... salary range ...
Schedule
... onsite requirement ...
We need to ensure we preserve all substantive information from the posting. Let's extract each piece. Company description (intro): "Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets." We can include that as part of About the role? Actually About the role should describe the role, not company. But we could include company description as part of About the role or maybe a separate "About the company" but not a heading we have. Since we only have headings for About the role, Responsibilities, etc. We could put company description in About the role paragraph before role specifics. That's okay. Then role description: "Position The Associate Director, Clinical Study Management, EMEA/LATAM will be responsible for overseeing the execution of clinical trials in oncology and other therapeutic areas, as required. This role will require onsite presence a minimum of 3 days a week to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration. The successful candidate will work closely with cross-functional Clinical Research & Development teams to ensure successful completion of studies within timelines and budget, with a focus on exquisite quality to support operational excellence and world class inhouse clinical study management. This role requires a minimum of 3 days per week onsite (or more, as business needs require) in either our Jersey City (NJ), or Millbrae (CA) offices." We need to avoid duplication of onsite sentence; we can combine. Thus About the role paragraph: combine company description and role responsibilities overview (excluding detailed duties). We'll produce a paragraph that includes company description and role overview. Now Responsibilities: list from "What You’ll Do". Let's extract each bullet: - Team leader and builder, who manages trial deliverables, timelines in assigned protocols across EMEA and LATAM to meet country commitments and regulatory requirements. - Works with minimal oversight from Clinical Operations Senior Director or Director, in collaboration with Clinical Operations teams and Clinical Research and Development functional teams. - Ensure that clinical studies are conducted in accordance with approved protocols, ICH-GCP, EMEA, PMDA and other relevant regulations and guidelines. - Manage ancillary (non CRO) vendor relationships and performance to ensure that clinical studies are completed in accordance with contract specifications of time, cost and quality ensuring compliance with applicable regulations, guidelines, and company policies. - Work with finance, legal, external vendors and clinical sites to ensure the assigned studies are meeting the target milestones. - Proven experience managing multi-center global clinical trials (Phases I–IV), with familiarity with regional nuances. - Keep up to date with regional regulations, health authority frameworks, treatment landscape and country requirements. - Manage regional resource planning, budgeting, forecasting, and key performance indicators (KPIs) for the region. - Provide direction to cross-functional study teams to ensure successful study execution. - Provide regular updates on study progress to stakeholders (e.g., Clinical Operations, Project & Portfolio Management, Clinical Research). - Ensure that all study-related documents are accurate, complete, timely and filed appropriately in all clinical (Veeva TMF), regulatory, safety and finance systems. - Oversee and be in compliance with Eikon processes, SOPs, clinical supply and ancillary supplies management, import/export requirements, insurance supply management. - Expected to lead, manage, hire regional Clinical Operations Study Management personnel across EMEA and LATAM, as required, to support operational excellence. - Contribute to initiatives and projects adding value to Eikon Therapeutics. Note: Some of these are more like qualifications (e.g., "Proven experience managing multi-center global clinical trials (Phases I–IV), with familiarity with regional nuances.") but they are listed under What You’ll Do. We'll keep them as responsibilities. Now Qualifications: list from Qualifications section plus About You attributes. Qualifications bullet list: - Minimum of 10 years of related experience with a Bachelor’s degree; or 8 years and a post graduate degree. - Fluency in English (strong reading, writing, and speaking skills and an ability to effectively communicate with colleagues and stakeholders at all levels) is required and ability to speak multiple EMEA/LATAM languages is a plus for this role. - In-depth knowledge of ICH-GCP, EMEA/LATAM guidelines and other relevant regulations and guidelines. - Proven ability to manage clinical studies within timelines and budgets while maintaining high quality standards and patient safety. - Strong leadership and communication skills, with a demonstrated ability to work collaboratively with cross-functional teams. - Experience with management of the budget, resources, headcount, processes and controls, productivity, quality and project delivery. - High sense of accountability and urgency in order to prioritize deliverables. - Growth mindset and capable of working independently. About You attributes (to add): - Collaborative, solutions oriented, flexible. - Global clinical operational experience. - Passion for excellence in advancing patient care in oncology or neuroscience. We could combine some. Now Benefits: list from "At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:" then list: - 401k plan with company matching - Medical (premiums covered by Eikon at 95%) - Dental and vision insurance (premiums covered by Eikon at 100%) - Mental health and wellness benefits - Weeklong summer and winter holiday shutdowns